JANESVILLE, Wis.--(BUSINESS WIRE)--SHINE Medical Technologies LLC, the Institute of Organic Chemistry and Biochemistry (IOCB Prague) and GE Healthcare today announced the production of patient dose quantities of the therapeutic isotope lutetium-177 (Lu-177). The lot passed GE Healthcare’s quality control testing, including internationally recognized radionuclide purity (RNP) standards. The delivery of Lu-177 in this quantity and purity demonstrates the suitability of the IOCB technology for Lu-177 production. It is a major step toward commercial production of the therapeutic isotope by SHINE.
Last May, SHINE entered an agreement with IOCB Prague that granted the company exclusive access to IOCB Prague’s novel technology, which is used to separate lutetium from enriched ytterbium targets. The technology enabled the production of the non-carrier-added (nca) Lu‑177 supplied to GE Healthcare. The isotope was produced in collaboration with the Nuclear Physics Institute in Czechia. The Nuclear Physics Institute and IOCB Prague are members of the Czech Academy of Sciences.
Lu-177 is used to treat neuroendocrine cancers. It also shows promise for the treatment of metastatic prostate and other cancers. The isotope is a low-energy beta-particle emitter that works by directly irradiating cancer cells after being delivered to the cancer site by a targeting molecule.
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“Non-carrier-added Lu-177 at the dosage and purity delivered to us bodes well for the potential to provide physicians and patients with a vital, highly effective therapeutic isotope,” said Charles Shanks, GE Healthcare’s principal engineer, Life Sciences. “Lu-177 is one of the key drivers of growth in the medical isotope market. It represents a major opportunity to better serve the market.”
“The delivery of patient dose quantities of Lu-177 to GE Healthcare is a significant step forward for SHINE Therapeutics,” said Katrina Pitas, the vice president and general manager of SHINE Therapeutics. “Together with our collaborators from the Czech Academy of Sciences, we have demonstrated the capability to produce Lu-177 at a very high standard of purity. We look forward to continuing to work with GE Healthcare to move Lu-177 closer to commercialization and the patients who will benefit from it most.”
“Producing clinically relevant doses of any therapeutic radionuclide is not easy and we have demonstrated that our technology can meet the challenge for nca Lu-177,” said Dr. Miloslav Polasek of IOCB Prague. “I am very grateful to the SHINE, IOCB and NPI teams for the progress we are making together.”